BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X ASCENDING AORTIC PROSTHESIS

    MDR report key: 6312417 · Received February 8, 2017

    Report

    Report Number
    1649833-2017-00016
    Event Type
    Death
    Date Received
    February 8, 2017
    Date of Event
    December 14, 2016
    Report Date
    April 20, 2017
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS. THE MANUFACTURING RECORDS FOR THE ONXAAP-19 PROSTHESIS, SN (B)(4) WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE ONXAAP-19, SN (B)(4), IMPLANTED (B)(6) 2016 IN (B)(6) FEMALE PATIENT WHO DIED THE FOLLOWING DAY. MANUFACTURER BECAME AWARE OF THE DEATH THROUGH AN ONLINE OBITUARY WHICH DID NOT INDICATE A CAUSE. NO CLINICAL INFORMATION WAS MADE AVAILABLE. THE PATIENT DID NOT SURVIVE THE SURGERY/RECOVERY PERIOD, WHICH CLASSIFIES THIS AS AN EARLY MORTALITY, A SUBSET OF ALL-CAUSE MORTALITY [AKINS ET AL. 2008]; BUT WE HAVE NO INFORMATION TO SUPPORT ANY CONCLUSION AS TO WHETHER OR NOT IT WAS VALVE RELATED. IN AN ANALYSIS OF AORTIC VALVE OPERATIONS IN THE STS DATABASE FROM 2002 TO 2010, 80% OF PATIENTS HAD A PREDICTED RISK OF MORTALITY (PROM) OF <4% AND AN ACTUAL MEAN MORTALITY RATE OF 1.4%. FOURTEEN PERCENT HAD A PROM OF 4% TO 8% AND AN ACTUAL MEAN MORTALITY RATE OF 5.1%, AND 6% OF PATIENTS HAD A PROM OF >8% AND AN ACTUAL MORTALITY RATE OF 11.1% [NISHIMURA ET AL. 2014). DEATHS IN THIS EVALUATION ARE UNRELATED TO THE DEVICE IMPLANTED AND REPRESENT OUTCOMES DUE TO THE TRAUMA OF SURGERY. WHILE THESE ARE GENERAL EVALUATIONS, THE PRESENCE OF COMORBIDITIES CAN INCREASE THE RISK OF A NEGATIVE OUTCOME. HOWEVER, WE HAVE NO INFORMATION AS TO WHETHER OR NOT COMORBIDITIES EXISTED IN THIS PARTICULAR CASE. ROOT CAUSE FOR THIS EVENT IS EARLY MORTALITY. NOT ENOUGH INFORMATION TO DETERMINE WHAT, IF ANY, RELATIONSHIP THE DEATH OF THE PATIENT HAD TO DO WITH THE VALVE. NO FURTHER ACTION WARRANTED.

    Description of Event or Problem · 1

    IMPLANT REGISTRATION CARD RECEIVED SHOWS IMPLANT DATE OF 12/13/2016. OBITUARY FOUND MATCHING PATIENT NAME AND BIRTHDAY HAS A DEATH AT (B)(6) 2016. ADDITIONAL INFORMATION IS PENDING.

    Description of Event or Problem · 1

    IMPLANT REGISTRATION CARD RECEIVED SHOWS IMPLANT DATE OF (B)(6) 2016. OBITUARY FOUND MATCHING PATIENT NAME AND BIRTHDAY HAS A DEATH AT (B)(6) 2016. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92783 ON-X ASCENDING AORTIC PROSTHESIS HEART VALVE MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-19

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death